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primaLOK FF

FDA UDI

Class U (US FDA UDI)

by Wenzel Spine

Identity

Trade Name
primaLOK FF FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
Threaded Implant Holder Shaft - Cannulated FDA UDI
Model / Reference
800-1212 FDA UDI
Description
Threaded Implant Holder Shaft - Cannulated FDA UDI

Identifiers

Primary DI / UDI-DI
00813210022027 FDA UDI
510(k) Number
K102438 FDA UDI
FDA Product Code
MRW FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic inorganic implant inserter/extractor, reusable

primaLOK FF by Wenzel Spine — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.

Cleared under the same submission

K102438 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wenzel Spine

Sources (1)

  • FDA UDI 31538b82-2800-4025-a134-ec76b6a2bb18 35 fields · synced May 30, 2026